Regulatory approval

Published by the Food and Drug Administration. Approved

The U.S. Food and Drug Administration granted approval to palbociclib in combination with an aromatase inhibitor as an initial endocrine-based therapy for treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer. This indication is based on PALOMA-2 (NCT01740427), an international, randomized, double-blind, parallel-group, multicenter study of palbociclib plus letrozole versus placebo plus letrozole.

This is written in the approval document as:

IBRANCE is a kinase inhibitor indicated for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in combination with an aromatase inhibitor as initial endocrine-based therapy.

Citation

Pfizer. Ibrance (palbociclib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/207103s024lbl.pdf. Revised June 2026. Accessed October 13, 2026.

Therapeutic response

Precision oncology relationships for therapeutic response derived from this regulatory approval.

Organizations	Biomarkers	Cancer types	Therapies
FDA (2)	ER positive, HER2-negative	Invasive Breast Carcinoma	Letrozole, Palbociclib
FDA (2)	HER2-negative, PR positive	Invasive Breast Carcinoma	Letrozole, Palbociclib
FDA (2)	ER positive, HER2-negative, PR positive	Invasive Breast Carcinoma	Letrozole, Palbociclib

Contributions

Date	Contributor	Description
2024-10-30	Van Allen lab	Initial access of FDA approvals
2019-09-19	Food and Drug Administration	Indication received traditional approval.